BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 1791395 · Received August 10, 2010

    Report

    Report Number
    6000094-2010-01444
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    January 8, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) A LOW BATTERY VOLTAGE WAS MEASURED; HOWEVER, ELECTRICAL ANALYSIS DID NOT FIND ANY ANOMALIES WITHIN THE DEVICE OR THE HYBRID. THE HYBRID HAD NOMINAL CURRENT DRAIN. THE CAUSE OF THE BATTERY DEPLETION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    T WAS REPORTED THAT AN IMPLANTABLE DEFIBRILLATOR WAS REPLACED DUE TO END OF SERVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. C174AWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD